Clinical Scientific Expert I

“150 Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs at study and program level, thereby supporting Novartis in reimagining medicine for patients worldwide.”
- Your responsibilities include, but are not limited to:
- Responsibility for ensuring high quality clinical trial data review/insights and analysis as advised by the Integrated Clinical Trial Team (iCTT)
- Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues.
- Chips in to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.
- In conjunction with the relevant line functions, may supply to Case Report Form (CRF) development, and support the implementation of data capture tools.
- Chip in to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
- May supply (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications.
- May support pharmacovigilance activities (e.g., reviewing/chipping in to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required. Produce training materials and provide training to iCTT.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- Sophisticated degree in life sciences/healthcare (or clinically relevant degree) is required. PhD, MBBS, BDS, MD strongly preferable. Proficient English (oral and written).
- 1 year experience in Pharmaceutical industry/ clinical research organization. Basic knowledge in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization.
- Work experience in clinical operations preferable. Strong social skills - Ability to work under pressure. Good negotiation and conflict resolution skills. Collaborates across boundaries for shared success
- Resolve issues with mínimal direction and understands when to raise. Fundamental knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Novartis
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

**Division**
- Global Drug Development

**Business Unit**
- GDO GDD

**Country**
- India

**Work Location**
- Hyderabad, AP

**Company/Legal Entity**
- Nov Hltcr Shared Services Ind

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No